Changchun GeneScience's GenSci143 clinical trial application accepted by FDA

Changchun High & New Technology Industry Group announced that its subsidiary, Changchun GeneScience Pharmaceutical Co., Ltd., received notification from the U.S. FDA that its clinical trial application for GenSci143 for injection has been accepted. The application, with acceptance number 177763, seeks approval for a new drug clinical trial for the treatment of advanced solid tumors.

GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, developed in-house by GeneScience. It aims to deliver chemotherapy and potentially enhance tumor immunity. The drug combines with B7-H3 or PSMA, internalizes into lysosomes, and releases a TOPO-I inhibitor toxin to kill tumor cells.

The company previously disclosed on August 22, 2025, that its clinical trial application for GenSci143 for advanced solid tumors in China had been accepted by the National Medical Products Administration. The company will actively advance this research project, noting that pharmaceutical product development involves high technology, high risk, and long cycles with many uncertain factors.